Aranesp(R) (Darbepoetin Alfa) Approved for Use in All European Paediatric Patients with Chronic Renal Failure Anaemia

European Commission Expands Aranesp Indication to Include All Paediatric Patients

Amgen (Europe) GmbH today announced that the European Commission
has approved Aranesp(R) (darbepoetin alfa) for the treatment of
anaemia associated with chronic renal failure (CRF), also known as
chronic kidney disease (CKD), in all European paediatric patients on
dialysis or not on dialysis. For patients with CRF, Aranesp was
previously indicated for the treatment of adults and only children
greater than or equal to 11 years of age.

"Consistent with Amgen's ongoing commitment to improving the lives
of patients with chronic renal failure and anaemia, we are delighted
that the European Commission has approved expanding Aranesp's
indication to now include adult and all paediatric patients," said
Willard Dere, M.D., senior vice president and international chief
medical officer, Amgen. "Based on new data that Amgen submitted, the
expanded indication is a positive demonstration of Aranesp's
longstanding favorable safety and efficacy profile in CRF patients."

Aranesp prescribing guidance is given separately for adult and
paediatric patients in the updated approved Summary of Product
Characteristics (SmPC). Treatment for paediatric patients younger than
one year of age has not been studied. Since its introduction in 2001,
Aranesp has been used in over 2.7 million patients across both its
nephrology and oncology indications.(1)

About CKD Anaemia

According to recent research, 10 percent of Europeans suffer from
CKD,(2) with many more at an elevated risk for kidney disease. CKD is
a progressive and irreversible condition characterised by kidney
damage and impaired kidney function. One of the most common symptoms
of CKD is anaemia, which is often under-recognised and
under-treated.(3) Anaemia occurs when failing kidneys no longer
produce enough erythropoietin, resulting in reduced red blood cell
production and haemoglobin levels. Anaemia can have a major impact on
a patient's health and quality of life.(4) Symptoms include fatigue,
weakness, shortness of breath, difficulty concentrating or confusion,
dizziness or fainting, pale skin, rapid heartbeat and feeling
unusually cold.

About Aranesp

Aranesp was granted marketing authorization by the European
Commission in 2001 for the treatment of anaemia associated with
chronic renal failure (CRF), in adults and paediatric subjects 11
years of age or older. In 2002, the European Commission approved
Aranesp for the treatment of anaemia in adult cancer patients
receiving chemotherapy with solid tumours. This patient population was
subsequently expanded in 2003 to include treatment of symptomatic
anaemia in adult cancer patients with non-myeloid malignancies
receiving chemotherapy. Approval was granted in 2004 for extended
dosing intervals of once-every-three-weeks in the treatment of anaemia
in adult cancer patients with non-myeloid malignancies who are
receiving chemotherapy and up to once-per-month Aranesp administration
in the treatment of anaemia in chronic kidney disease (CKD) patients
not on dialysis. In 2006, the Aranesp label was updated to allow CKD
patients on dialysis to switch from rHuEPO one to three times a week
to Aranesp every two weeks. In 2007, the Aranesp label was updated to
allow for treatment of anaemia associated with CRF, in all European
paediatric patients on dialysis or not on dialysis.

Aranesp was approved by the U.S. Food and Drug Administration
(FDA) in September 2001 for the treatment of anaemia associated with
CRF for patients on dialysis and patients not on dialysis. In July
2002, the FDA approved weekly dosing of Aranesp for the treatment of
anaemia caused by concomitantly administered chemotherapy in patients
with non-myeloid malignancies and in March 2006, the FDA approved
every-three-week dosing in these patients.

Important EU Aranesp Safety Information

Aranesp is contraindicated in patients with uncontrolled
hypertension. Erythropoietic therapies may increase the risk of
thrombotic and other serious events; regional guidelines should be
referred to for target and maximum hemoglobin levels, and dose
adjustment rules should be performed in line with regional prescribing
information.

The most commonly reported side effects in clinical trials were
arthralgia, edema, injection site pain, and thromboembolic event
reactions. Prescribers are recommended to consult regional prescribing
information before prescribing Aranesp, including side-effects,
precautions and contra-indications.

Important U.S. Aranesp Safety Information

Use the lowest dose of Aranesp(R) that will gradually increase the
haemoglobin concentration to the lowest level sufficient to avoid the
need for red blood cell transfusion.

Aranesp(R) and other erythropoiesis-stimulating agents (ESAs)
increased the risk for death and for serious cardiovascular events
when administered to target a haemoglobin of greater than 12 g/dL

Cancer Patients: Use of ESAs

-- Shortened the time to tumour progression in patients with
advanced head and neck cancer receiving radiation therapy when
administered to target a haemoglobin of greater than 12 g/dL,

-- Shortened overall survival and increased deaths attributed to
disease progression at 4 months in patients with metastatic
breast cancer receiving chemotherapy when administered to
target a haemoglobin of greater than 12 g/dL,

-- Increased the risk of death when administered to target a
haemoglobin of 12 g/dL in patients with active malignant
disease receiving neither chemotherapy or radiation therapy.
ESAs are not indicated for this population.

Patients receiving ESAs pre-operatively for reduction of
allogeneic red blood cell transfusions: A higher incidence of deep
venous thrombosis was documented in patients receiving Epoetin alfa
who were not receiving prophylactic anticoagulation. Aranesp(R) is not
approved for this indication.

Aranesp is contraindicated in patients with uncontrolled
hypertension.

About Amgen

Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
first companies to realize the new science's promise by bringing safe
and effective medicines from lab, to manufacturing plant, to patient.
Amgen therapeutics have changed the practice of medicine, helping
millions of people around the world in the fight against cancer,
kidney disease, rheumatoid arthritis, and other serious illnesses.
With a deep and broad pipeline of potential new medicines, Amgen
remains committed to advancing science to dramatically improve
people's lives. To learn more about our pioneering science and our
vital medicines, visit www.amgen.com.

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(1) Amgen data on file

(2) De Zeeuw D, Hillege HL, de Jong PE. The Kidney, a cardiovascular
risk marker, an a new target for therapy. Kidney Int Suppl 2005;
98: S25-S29.

(3) Obrador GT, Ruthazer R, Arora P, Kausz AT, Pereira BJ. Prevalence
of and factors associated with suboptimal care before initiation
of dialysis in the United States. J Am Soc Nephrol 1999; 10:
1793-1800.

(4) Bethseda M. Chapter 3: Patient characteristics. In: USRDS,
editor. US Renal Data System 2003 Annual Data Report: Atlas of
End-Stage Renal Disease in the United States, National
Institutes of Health, National Institute of Diabetes and
Digestive and Kidney Diseases: US Renal Data System, 2003.
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